Endoprosthesis device and method

• US 4,892,550 A
• Filed: 12/30/1985
• Issued: 01/09/1990
• Est. Priority Date: 12/30/1985
• Status: Expired due to Fees

• Current Assignee: Donald L. Huebsch
• Original Assignee: Donald L. Huebsch
• Inventors: Huebsch, Donald L.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Prizant, James
• Application Number:
  US06/814,690
• Time in Patent Office: 1,471 Days
• Field of Search: 128/92 R, 623/14, 623/16, 623/20, 623/23, 623/22
• US Class Current: 623/23.19
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8808 with sealing collar for bone cavity
• CPC Class Codes: A61B 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61F 2/30734 Modular inserts, sleeves or augments, e.g. placed on proximal part of stem for fixation purposes or wedges for bridging a bone defect
• CPC Class Codes: A61F 2/30744 End caps, e.g. for closing an endoprosthetic cavity
• CPC Class Codes: A61F 2/30907 Nets or sleeves applied to surface of prostheses or in cement
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/4637 for connecting or disconnecting two parts of a prosthesis
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/30332 Conically- or frustoconically-shaped protrusion and recess
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30433 using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30515 using a locking wedge or block
• CPC Class Codes: A61F 2002/30563 having elastic means or damping means, different from springs, e.g. including an elastomeric core or shock absorbers
• CPC Class Codes: A61F 2002/30581 having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30584 : filled with gas
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30594 : slotted, e.g. radial or meridian slot ending in a polar aperture, non-polar slots, horizontal or arcuate slots
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30774 : internally-threaded
• CPC Class Codes: A61F 2002/30886 : externally-threaded
• CPC Class Codes: A61F 2002/30917 : for avoiding direct contact between bone and implant, e.g. extensible membrane for preventing contamination or for easy removal
• CPC Class Codes: A61F 2002/30975 : made of two halves
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/3627 : with lateral apertures, holes or openings
• CPC Class Codes: A61F 2002/3647 : pierced with a longitudinal bore
• CPC Class Codes: A61F 2002/365 : Connections of heads to necks
• CPC Class Codes: A61F 2002/3652 : Connections of necks to shafts
• CPC Class Codes: A61F 2002/368 : with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft
• CPC Class Codes: A61F 2002/4619 : for extraction
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2002/4641 : for disconnecting
• CPC Class Codes: A61F 2002/465 : using heating means
• CPC Class Codes: A61F 2002/467 : for measuring fluid pressure
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2310/00011 : Metals or alloys

Abstract

Disclosed is an endoprosthesis device and method of installing the same immovably in a medullary canal under a constant predetermined uniformly distributed pressure. The rigid prosthesis stem is typically embraced by an elastomeric element designed for continuous pressurization into compressed resilient anchorage with the medullary canal surface. The tubular elastomeric element can be pressurized in various ways such as by a captive gas, or by a fluent material until this material takes a set, or by a combination of pressurized gas and settable fluent material. When a captive pressurized gas is used, along or with a settable material, it provides a major portion of the elastic energy anchoring the prosthesis immovably in place; and when a settable pressurizing medium is used, the elastic energy is stored in the compressed thick elastomer. The constant elastic energy fosters bone growth to augment prosthesis anchorage. Permanent anchorage is achieved virtually instantly following alignment and pressurization of the prosthesis. When a settable material is used, the stem may include a withdrawable wedge to facilitate separation of the remainder of the prosthesis from the medullary canal. The expandable/compressible elastic component readily compensates for irregularity in the canal wall and requires a minimum of preliminary preparation of its surface.

Claims

1. A pressurizable elastic endoprosthesis anchoring apparatus freely insertable into a medullary canal and thereafter immovably anchorable thereto comprising:

an elongated load bearing stem;

an elastic member mounted around and extending lengthwise of said stem; and

means for compressing said elastic member radially outward into pressurized contact with the juxtaposed surface of the medullary canal after insertion therein;

the elastic member being fluid impervious and having an internal cavity, and said means for compressing said elastic member including means for introducing a fluent medium under pressure into said cavity to expand said elastic member into pressurized contact with said surface of the medullary canal and to continuously maintain the elastic member compressed in resilient pressure contact with the medullary canal surface, said elastic member being effective to distribute elastic pressure substantially uniformly to the surface area of the medullary canal in contact therewith and to conform to irregularities present in the juxtaposed surface portion of the medullary canal, said uniformly distributed elastic pressure applied continuously by the elastic member to the medullary canal being effective to anchor said endoprosthesis immovably therein.

2. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said means for compressing said elastic member includes means for introducing a pressurized fluent medium between said stem and said elastic member adapted to set rigidly and for maintaining the same pressurized while said fluent medium sets in a rigid condition thereby to maintain said elastic means elastically compressed and pressurized indefinitely.

3. An endoprosthesis anchoring apparatus as defined in claim 2 characterized in that a major portion of said stem is noncircular in cross section whereby said stem is nonrotatable relative to said rigid medium after said medium sets.

4. An endoprosthesis anchoring apparatus as defined in claim 2 characterized in that said pressurized fluent medium is effective to expand said elastic member into conformity with irregularities in the surface of a medullary canal while taking a rigid set thereby to anchor said stem immovably in place in said canal.

5. An endoprosthesis anchoring apparatus as defined in claim 2 characterized in that said fluent medium is readily friable in response to impact forces applied thereto in a manner to effect removal of the prosthesis if removal is desired.

6. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said means for compressing said elastic member with said fluent medium includes means for introducing pressurized gas into said cavity and for retaining said gas captive therein under pressure thereby to maintain said elastic member resiliently compressed in uniformly distributed pressure contact with said medullary canal.

7. An endoprosthesis anchoring apparatus as defined in claim 6 characterized in the provision of means for releasing said pressurized gas from said cavity in said elastic member thereby releasing said endoprosthesis for unobstructed withdrawal from said medullary canal.

8. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said elastic member comprises an elongated elastomeric bladder embracing the major portion of said stem and secured to axially spaced apart portions thereof in a fluid tight manner.

9. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said stem is subdivided into a plurality of members longitudinally thereof including a first member between at least a member to either side thereof and each of which members extend axially beyond said elastic member and including means for detachably connecting a head thereto.

10. An endoprosthesis anchoring apparatus as defined in claim 9 characterized in the provision of fastener means normally detachably interconnecting said plurality of stem members;

and said first member being withdrawable lengthwise of said stem when said fastener means is removed.

11. An endoprosthesis anchoring apparatus as defined in claim 10 characterized in the provision of means normally detachably interconnecting the remainder of said plurality of stem members, and said first member being withdrawable lengthwise of said stem upon detachment of said fastener means.

12. An endoprosthesis anchoring apparatus as defined in claim 10 characterized in that, after the withdrawal of said first stem member, the other members of said stem are collapsible toward one another to facilitate separation of said elastic member from a medullary canal and the removal of said endoprosthesis therefrom.

13. An endoprosthesis anchoring apparatus as defined in claim 9 characterized in that said first member is a blade the opposite sides of which converge toward one another from the thicker outer end thereof.

14. An endoprosthesis anchoring apparatus as defined in claim 9 characterized in that said members to either side of said first member are movably connected to one another adjacent the inner, thinner end of said first member.

15. An endoprosthesis anchoring apparatus as defined in claim 9 characterized in that said prosthesis includes a head having a threaded well mateable with the composite of threaded extensions on said first stem member and on the stem members to either side of said first stem member when said threaded extensions are in aligned side-by-side contact.

16. An endoprosthesis anchoring apparatus as defined in claim 15 characterized in the provision of puller means having a first portion securable to the outer end of said first stem member and a second portion engageable with the outer end of at least one of said stem members to either side of said first stem member and manipulatable to withdraw said first member from between said members to either side thereof.

17. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said stem is formed with a radially opening groove encircling the outer end portion thereof;

and said elastic member having a portion thereof shaped and sized to seat snugly in said groove; and

the exterior of said elastic member radially opposite said groove having a close telescopic fit with the adjacent wall of a medullary canal when inserted therein.

18. An endoprosthesis anchoring apparatus as defined in claim 9 characterized in that said plurality of stem members are generally elliptical in cross section with the plane of said first stem member lying generally parallel with the major axis of said stem.

19. An endoprosthesis anchoring apparatus as defined in claim 1 characterized in that said elastic member comprises a thick-walled elastomeric bladder embracing said stem and having the opposite ends thereof in fluid tight contact with the adjacent end portions of said stem;

and said bladder being chargeable with an initially fluent rigidly settable medium maintained pressurized while said medium takes a generally rigid set thereby to hold said bladder elastically pressed against the juxtaposed surface of a medullary canal.

20. That method of anchoring an endoprosthesis immovably in a medullary canal comprising:

providing an elongated rigid load bearing stem;

embracing said stem with an elongated elastomeric member;

which is fluid impervious and has an internal cavity;

securing opposite end portions of said elastomeric member to a respective end of said stem;

inserting said stem and elastomeric member into the open end of a medullary canal; and

pressuring said elastomeric member inwardly of an outer wall thereof with a fluent material introduced under pressure into said internal cavity to expand said outer wall of the elastomeric member radially outwardly into pressurized contact with a juxtaposed surface of the medullary canal and continuously maintaining the outer wall of the elastomeric member compressed in resilient pressure contact with the medullary canal surface, said elastomeric member being effective to distribute elastic pressure substantially uniformly to the surface area of the medullary canal in contact therewith and conform to irregularities present in the juxtaposed surface portion of the medullary canal while said uniformly distributed elastic pressure applied continuously by the elastomeric member to the medullary canal is effective to anchor said endoprosthesis immovably therein.

21. That method defined in claim 20 characterized in the step of utilizing an elastomeric member having inner and outer walls constructed to provide a closed annular cavity therebetween;

and charging said cavity with an initially fluent rigidly settable medium under a predetermined superatmospheric pressure and maintaining said pressure thereon while said fluent medium takes a rigid set thereby anchoring said prosthesis immovably against the surface of said medullary canal under uniformly distributed elastic pressure.

22. That method defined in claim 20 characterized in the step of pressurizing the inner side of said elastomeric member with an initially fluent rigidly settable medium maintained under a predetermined pressure while the same sets and selected for its friability when subjected to deliberately applied impact and shock forces imposed thereon to permit withdrawal of said endoprosthesis from a medullary canal.

23. That method defined in claim 20 characterized in the step of pressurizing the inner side of said elastomeric member with an initially fluent rigidly settable medium maintained under a predetermined pressure until the same sets into a rigid mass.

24. That method defined in claim 21 characterized in the step of pressing said elastomeric member against the surface of said medullary canal with a uniformly distributed pressure typically effective to foster and invigorate growth of the portion of the medullary canal opposed to and in contact with said elastomeric member thereby to augment the anchorage of said endoprosthesis thereto.

25. That method defined in claim 21 characterized in the step of precisely aligning a medullary canal, said endoprosthesis and an acetabular socket therefor before pressurizing said elastomeric member.

26. That method defined in claim 25 characterized in the step of pressurizing said elastomeric member with an initially fluent rigidly settable medium which takes a rigid set with said medullary canal, said endoprosthesis and said acetabular socket in precise alignment.

27. A pressurizable elastic endoprosthesis anchoring apparatus freely insertable into a medullary canal and thereafter immovably anchorable thereto comprising:

a rigid main body including a load bearing stem supporting a head on one end thereof;

tubular elastomeric means having at least one tubular outer wall embracing said stem with opposite end portions thereof secured to said stem in a fluid-tight manner to provide at least one closed annular cavity; and

means for pressurizing said annular cavity to hold said at least one tubular outer wall pressed into resilient continuously maintained pressurized contact with the juxtaposed surface of a medullary canal to distribute elastic pressure substantially uniformly to the juxtaposed surface area of the medullary canal in contact therewith and to conform to irregularities present in said surface and to anchor said endoprosthesis immovably therein under said uniformly distributed elastic pressure continuously applied by the outer wall of said elastomeric means.

28. An endoprosthesis anchoring apparatus as defined in claim 27 characterized in that said annular cavity is charge with initially fluent medium which takes a rigid set and maintained pressurized to a predetermined pressure until said medium takes a rigid set.

29. An endoprosthesis anchoring apparatus as defined in claim 28 characterized in the provision of means for venting air from said cavity while charging the same with said fluent medium.

30. An endoprosthesis anchoring apparatus as defined in claim 27 characterized in that said annular cavity is charge with pressurized gas maintained permanently pressurized to a predetermined pressure.

31. An endoprosthesis anchoring apparatus as defined in claim 27 characterized in that said tubular elastomeric means includes a plurality of flexible concentric walls embracing said stem and cooperating therewith to form closed inner and outer cavities;

and said outer cavity being substantially evacuated before insertion into a medullary canal.

32. An endoprosthesis anchoring apparatus as defined in claim 31 characterized in that said outer cavity is adapted to be filled with a captive quantity of gas pressurized to a predetermined pressure to hold the outermost wall of said tubular elastomeric means pressed resiliently and immovably against the surface of said medullary canal.

33. An endoprosthesis anchoring apparatus as defined in claim 31 characterized in that said outer cavity includes means for sealing the same closed filled with gas substantially at atmospheric pressure;

and means for sealing said inner cavity closed with an initially fluent rigidly settable medium pressurized to a predetermined superatmospheric pressure thereby to pressurize the gas in said outer cavity and to hold the outer wall of said elastomeric means immovably anchored to the juxtaposed surface of a medullary canal under uniformly distributed predetermined pressure.

34. An endoprosthesis anchoring apparatus as defined in claim 30 characterized in that said inner cavity is charged with an initially fluent medium compounded to take a rigid set.

35. An endoprosthesis anchoring apparatus as defined in claim 27 characterized in that said elastomeric means comprises a pair of flexible concentric elastic walls loosely embracing said stem, the opposite ends of said walls being sealed to one another and to the respective adjacent ends of said stem and cooperating with said stem to provide a pair of independent inner and outer cavities;

and passage means for introducing a pressurized medium into at least one of said cavities to hold the outermost one of said elastic walls pressed under substantially uniformly distributed pressure contact with the juxtaposed surface of a medullary canal.

36. An endoprosthesis anchoring apparatus as defined in claim 35 characterized in that said inner cavity is chargeable with an initially fluent rigidly settable medium maintained under pressure until it takes a rigid set thereby to hold the walls of said tubular elastomeric means pressed together with the outermost of said walls in uniformly distributed pressure contact with a medullary canal.

37. An endoprosthesis anchoring apparatus as defined in claim 35 characterized in that the outer one of said cavities includes a trapped quantity of gas at substantially atmospheric pressure after said endoprosthesis has been inserted into a medullary canal;

and the inner one of said cavities being chargeable with a non-gaseous medium maintained under a predetermined superatmospheric pressure until said medium takes a rigid set and effective to compress the gas in said outer cavity to substantially the same pressure and thereby effective to press said outer elastic wall pressed immovably into conformity with the juxtaposed surface of a medullary canal.